New treatment option for Pregnancy Related
Official title Trial of Community-based Patient Navigation
ClinicalTrials.gov ID: NCT05588245
What this study is testing
- What it's testing
- This study will test the effectiveness of a community-based patient navigator intervention from mid-pregnancy through 12 month postpartum for a high-risk population of medically underserved women. The RCT will enroll 540 pregnant women before 20 weeks of pregnancy and randomly allocate them into two different study arms from the time of prenatal enrollment through 12 months postpartum.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- A pregnant woman or individual (inclusive of all gender identities) who is Black and English-speaking (by self-report),
- ≥18 years of age who is capable of consenting for oneself and who presents for prenatal care with a singleton pregnancy ≤ 20 weeks gestation...
- covered by Medicaid
- for whom the AHC-Health Related Social Needs Tool (administered as part of standard clinical care for prenatal patients) identifies ≥1 unmet social...
- expectation to receive prenatal care and deliver at Grady and be available through 12-months postpartum to assure opportunity for exposure to the...
You likely can't join if
- The intent to transfer care to a health system outside of metro Atlanta
- incarceration, which would interfere with intervention provision and outcome ascertainment
- adults unable to give consent
- individuals who are not yet adults
- prisoners
- cognitively impaired individuals with impaired decision-making capacity
See the full eligibility criteria
- A pregnant woman or individual (inclusive of all gender identities) who is Black and English-speaking (by self-report),
- ≥18 years of age who is capable of consenting for oneself and who presents for prenatal care with a singleton pregnancy ≤ 20 weeks gestation (confirmed by medical record),
- covered by Medicaid
- for whom the AHC-Health Related Social Needs Tool (administered as part of standard clinical care for prenatal patients) identifies ≥1 unmet social needs
- expectation to receive prenatal care and deliver at Grady and be available through 12-months postpartum to assure opportunity for exposure to the intervention, process, and outcome measure ascertainment.
- The intent to transfer care to a health system outside of metro Atlanta
- incarceration, which would interfere with intervention provision and outcome ascertainment
- adults unable to give consent
- individuals who are not yet adults
- prisoners
- cognitively impaired individuals with impaired decision-making capacity
- individuals who are not able to clearly understand and speak English (as the PPP-PN intervention is only available in English at this time)
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.